Brand Name | TRICUT® STRAIGHT SHAFT 4MM 11CM LONG |
Type of Device | BUR, EAR, NOSE AND THROAT |
Manufacturer (Section D) |
MEDTRONIC PUERTO RICO OPERATIONS CO. |
road 31, km. 24, hm 4 |
ceiba norte industrial park |
juncos PR 00777 |
|
Manufacturer (Section G) |
MEDTRONIC PUERTO RICO OPERATIONS CO. |
road 31, km. 24, hm 4 |
ceiba norte industrial park |
juncos PR 00777 |
|
Manufacturer Contact |
christy
cain
|
6743 southpoint drive north |
jacksonville, FL 32216
|
9043328353
|
|
MDR Report Key | 8901268 |
MDR Text Key | 154552861 |
Report Number | 3004209178-2019-15777 |
Device Sequence Number | 1 |
Product Code |
EQJ
|
UDI-Device Identifier | 20681490047450 |
UDI-Public | 20681490047450 |
Combination Product (y/n) | N |
Reporter Country Code | SN |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
08/16/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 1884004 |
Device Catalogue Number | 1884004 |
Device Lot Number | HG23GEG |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 07/29/2019 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
07/23/2019
|
Initial Date FDA Received | 08/16/2019 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 10/26/2017 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 15 YR |